Graphical user interface for monitoring and controlling use of medical devices

ABSTRACT

A device for treating a tissue region is supplied with a separate usage key card. The usage key card comprises a storage medium, which is formatted to contain an identification code unique to the usage key card. The usage key card is adapted to be read by a remote reader, to download the identification code for processing by a controller for the device. Processing of the identification code by the controller either enables or disables operation of the device according to prescribed criteria. A viewable image is generated on a display screen that changes in response to processing of the identification code.

RELATED APPLICATIONS

This application is a continuation of patent application Ser. No.11/299,955 filed Dec. 12, 2005 (now U.S. Pat. No. 7,922,715), which is adivisional of U.S. patent application Ser. No. 10/219,798, filed Aug.15, 2002 (now U.S. Pat. No. 6,994,704), which is a divisional of U.S.patent application Ser. No. 09/574,704, filed May 18, 2000 (now U.S.Pat. No. 6,464,689).

FIELD OF THE INVENTION

The invention is directed to systems and methods for monitoring andcontrolling use of medical devices.

BACKGROUND OF THE INVENTION

Use of medical devices intended to treat or diagnose conditions of thebody can sometimes generate stress on the material or materials fromwhich the devices are made. The material stress can alter the physicalcharacteristics of the devices, making future performance of the devicesunpredictable.

In addition, exposure to blood and tissue during use can entrapbiological components on or within many medical devices. Despitecleaning and subsequent sterilization, the presence of entrappedbiological components can lead to unacceptable pyrogenic reactions.

The effects of material stress and damage caused during a single use ofa medical device, coupled with the possibility of pyrogen reactions evenafter resterilization, reasonably justify imposing a single userestriction upon many medical devices.

SUMMARY OF THE INVENTION

The invention provides systems and methods for monitoring andcontrolling use of medical devices. The systems and methods employ acontroller to control operation of the device and a reader to downloadinformation to the controller. The systems and methods also include ausage key card adapted to be handled separate from the device andcomprising a storage medium formatted to contain an identification codeunique to the usage key card. Upon reading by the reader, theidentification code is downloaded to the controller. The controllerincludes a first data state prior to downloading of the identificationcode. A processing function for processing the identification codeenables operation of the device if the identification code correlates ina pre-established manner with the first data state. The processingfunction operates, in response to enabling operation of the device, tochange the first data state to a second data state that preventssubsequent operation of the device in response to downloading of theidentification code.

In one embodiment, the processing function causes the controller tocreate a table by registering unlike identification codes in memory asthey are downloaded by the reader. The controller enables operation ofthe device when a new identification code is registered in the table.

In one embodiment, the processing function causes the controller todisable operation of the device when the given identification codematches an identification code in the table.

In one embodiment, the processing function causes the controller toregister in the table, a time period of use of the device. In thisarrangement, the processing function causes the controller to disableoperation of the device when the time of use exceeds a prescribedperiod.

In one embodiment, the device applies radio frequency energy to thetissue region.

Features and advantages of the inventions are set forth in the followingDescription and Drawings, as well as in the appended Claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic view of a system for treating body sphinctersand adjoining tissue regions, which embodies features of the invention;

FIG. 2 is a perspective view, with portions broken away, of a deviceusable in association with the system shown in FIG. 1 having anoperative element for contacting tissue shown in a collapsed condition;

FIG. 3 is a perspective view, with portions broken away, of the deviceshown in FIG. 2, with the operative element shown in an expandedcondition;

FIG. 4 is a perspective view, with portions broken away, of the deviceshown in FIG. 2, with the operative element shown in an expandedcondition and the electrodes extended for use;

FIG. 5 is an enlarged view of the operative element shown in FIG. 4,with the electrodes extended for use;

FIG. 6 is a perspective view of a kit containing a device, such as shownin FIGS. 2 to 5, and a usage key card;

FIG. 7 is an enlarged, mainly schematic view of the usage key card shownin FIG. 6, embodied as a floppy disk, and also showing the pre-formattedfiles it contains;

FIG. 8 is a schematic view of a controller, which the system shown inFIG. 1 incorporates, showing the pre-programmed rules by whichinformation contained on the usage key card shown in FIGS. 6 and 7 isread and processed;

FIG. 9 is a schematic view of another processing device that readsinformation from the usage key card for further processing;

FIG. 10 is a left perspective views of an integratedgenerator/controller apparatus for use in association with a disposabletreatment device, the apparatus including a graphical user interface(GUI) that aids in monitoring and controlling the incidence of use ofthe disposable treatment device;

FIG. 11 is a representative SETUP display that can be implemented by theGUI shown in FIG. 10 as part of monitoring and controlling the incidenceof use of the disposable treatment device;

FIG. 12 is a representative EXCHANGE display that can be implemented bythe GUI shown in FIG. 10 as part of monitoring and controlling theincidence of use of the disposable treatment device; and

FIG. 13 is a flow chart showing the various states and modes that theapparatus shown in FIG. 10 employs in implementing the GUI in monitoringand controlling the incidence of use of the disposable treatment device.

The invention may be embodied in several forms without departing fromits spirit or essential characteristics. The scope of the invention isdefined in the appended claims, rather than in the specific descriptionpreceding them. All embodiments that fall within the meaning and rangeof equivalency of the claims are therefore intended to be embraced bythe claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows one embodiment of a system 10, which monitors and controlsthe use of an operative element 12. The system 10 is well adapted forassociation with single use, catheter-based devices. Therefore, in theillustrated embodiment, the operative element 12 is part of acatheter-based treatment device 26. It should be appreciated, however,that the system 10 is also adaptable for use with devices and methodsthat are not necessarily catheter-based.

I. The Treatment Device

In the illustrated embodiment, the device 26 includes a handle 28 made,e.g., from molded plastic. The handle 28 is sized to be convenientlyheld by a physician, to introduce the catheter tube 30 into the targetedtissue region.

The handle 28 carries a flexible catheter tube 30. The catheter tube 30can be constructed, for example, using standard flexible, medical gradeplastic materials. The catheter tube 30 has a distal end 34, whichcarries the operative element 12.

The operative element 12 can support, for example, a device for imagingbody tissue, such as an endoscope, or an ultrasound transducer. Theoperative element 12 can also support a device to deliver a drug ortherapeutic material to body tissue. The operative element 12 can alsosupport a device for sensing a physiological characteristic in tissue,such as electrical activity, or for transmitting energy to stimulate orform lesions in tissue.

In the illustrated embodiment, the device 26, in use, is intended totreat dysfunction of sphincters and adjoining tissue regions in theupper gastrointestinal tract, e.g., in the lower esophageal sphincterand adjacent cardia of the stomach, as well as in the lowergastrointestinal tract, e.g., in the intestines, rectum and anal canal.Still, it should be appreciated that the system 10 can be used inassociation with other devices and methods used to treat otherdysfunctions elsewhere in the body, which are not necessarilysphincter-related. For example, the various aspects of the inventionhave application in procedures requiring ablation of tissue throughoutthe body, or treatment of hemorrhoids, or restoring compliance to orotherwise tightening interior tissue or muscle regions.

In the illustrated embodiment, one function that the operative element12 is to perform is to apply energy in a selective fashion to a targetedbody region, which, for the purpose of illustration, can be the loweresophageal sphincter, or cardia, or both. The applied energy creates oneor more lesions, or a prescribed pattern of lesions, below the mucosalsurface of the esophagus or cardia. The subsurface lesions are formed ina manner that preserves and protects the mucosal surface against thermaldamage.

It has been discovered that natural healing of the subsurface lesionsleads to a physical tightening of the sphincter and/or adjoining cardia.The subsurface lesions can also result in the interruption of aberrantelectrical pathways that may cause spontaneous sphincter relaxation. Inany event, the treatment can restore normal closure function to thesphincter.

The structure of the operative element 12 to achieve this result canvary. A representative embodiment is shown in FIGS. 2 to 4, in which theoperative element 12 comprises a three-dimensional basket 56. The basket56 includes one or more spines 58, and typically includes from four toeight spines 58, which are assembled together by a distal hub 60 and aproximal base 62.

In the illustrated embodiment, an expandable structure 72 comprising aballoon is located within the basket 56. The balloon structure 72 can bemade, e.g., from a Polyethylene Terephthalate (PET) material, or apolyamide (non-compliant) material, or a radiation cross-linkedpolyethylene (semi-compliant) material, or a latex material, or asilicone material, or a C-Flex (highly compliant) material.

The balloon structure 72 presents a normally, generally collapsedcondition, as FIG. 2 shows. In this condition, the basket 56 is alsonormally collapsed about the balloon structure 72, presenting a lowprofile for deployment into the esophagus 10.

The catheter tube 30 includes an interior lumen, which communicates withthe interior of the balloon structure 72. A fitting 76 (e.g., asyringe-activated check valve) is carried by the handle 28. The fitting76 communicates with the lumen. The fitting 76 couples the lumen to asyringe 78 (see FIG. 3). The syringe 78 injects fluid under pressurethrough the lumen into the balloon structure 72, causing its expansion.

Expansion of the balloon structure 72 urges the basket 56 to open andexpand (see FIG. 3). The force exerted by the balloon structure 72, whenexpanded, is sufficient to exert an opening force upon the tissuesurrounding the basket 56.

Each spine 58 carries an electrode 66 (see FIG. 4). In the illustratedembodiment, each electrode 66 is carried within the tubular spine 58 forsliding movement. Each electrode 66 slides from a retracted position,withdrawn in the spine 58 (shown in FIG. 3) and an extended position,extending outward from the spine 58 (see FIG. 4) through a hole in thespine 58. A push-pull lever 68 on the handle 28 is coupled by one ormore interior wires to the sliding electrodes 66. The lever 68 controlsmovement electrodes between the retracted position (by pulling rearwardon the lever 68) and the extended position (by pushing forward on thelever 68). The electrodes 66 have sufficient distal sharpness andstrength, when extended, to penetrate a desired depth into tissue thesmooth muscle of the esophageal or cardia 20 wall. The desired depth canrange from about 4 mm to about 5 mm.

In this arrangement (see FIG. 1), the system 10 includes a generator 38to supply the treatment energy to the electrodes 66. In the illustratedembodiment, the generator 38 supplies radio frequency energy, e.g.,having a frequency in the range of about 400 kHz to about 10 mHz. Ofcourse, other forms of energy can be applied, e.g., coherent orincoherent light; heated or cooled fluid; resistive heating; microwave;ultrasound; a tissue ablation fluid; or cryogenic fluid.

A cable 40 extending from the proximal end of the handle 28 terminateswith an electrical connector 42. The cable 40 is electrically coupled tothe operative element 12, e.g., by wires that extend through theinterior of the handle 28 and catheter tube 30. The connector 42 plugsinto the generator 38, to convey the generated energy to the operativeelement 12.

The electrodes 66 are formed of material that conducts radio frequencyenergy, e.g., nickel titanium, stainless steel, e.g., 304 stainlesssteel, or a combination of nickel titanium and stainless steel.

In the illustrated embodiment (see FIG. 5), an electrical insulatingmaterial 70 is coated about the proximal end of each electrode 66. Whenthe distal end of the electrode 66 penetrating the smooth muscle of theesophageal sphincter 18 or cardia 20 transmits radio frequency energy,the material 70 insulates the mucosal surface of the esophagus 10 orcardia 20 from direct exposure to the radio frequency energy. Thermaldamage to the mucosal surface is thereby avoided. The mucosal surfacecan also be actively cooled during application of radio frequencyenergy, to further protect the mucosal surface from thermal damage.

In the illustrated embodiment (see FIG. 5), at least one temperaturesensor 80 is associated with each electrode. One temperature sensor 80senses temperature conditions near the exposed distal end of theelectrode 66, a second temperature sensor 80 is located on thecorresponding spine 58, which rests against the muscosal surface whenthe balloon structure 72 is inflated.

The system 10 (see FIG. 1) can also include certain auxiliary processingequipment, e.g., an external fluid delivery apparatus 44 for supplyingcooling liquid to the targeted tissue, e.g., through holes in thespines, and an external aspirating apparatus 46 for conveying liquidfrom the targeted tissue site, e.g., through other holes in the spine orelsewhere on the basket 56.

The system 10 also includes a controller 52. The controller 52, whichpreferably includes a central processing unit (CPU), is linked to thegenerator 38, the fluid delivery apparatus 44, and the aspiratingapparatus 46. Alternatively, the aspirating apparatus 46 can comprise aconventional vacuum source typically present in a physician's suite,which operates continuously, independent of the controller 52. Thecontroller 52 governs the delivery of processing fluid and, if desired,the removal of aspirated material.

The controller 52 also governs the power levels, cycles, and durationthat the radio frequency energy is distributed to the electrodes 66, toachieve and maintain power levels appropriate to achieve the desiredtreatment objectives. The controller 52 can condition the electrodes 66to operate in a monopolar mode. In this mode, each electrode 66 servesas a transmitter of energy, and an indifferent patch electrode (notshown) serves as a common return for all electrodes 66. Alternatively,the controller 52 can condition the electrodes 66 to operate in abipolar mode. In this mode, one of the electrodes comprises thetransmitter and another electrode comprises the return for thetransmitted energy. The bipolar electrode pairs can electrodes 66 onadjacent spines, or electrodes 66 spaced more widely apart on differentspines.

The controller 52 includes an input/output (I/O) device 54. The I/Odevice 54 allows the physician to input control and processingvariables, to enable the controller 52 to generate appropriate commandsignals. The I/O device 54 also receives real time processing feedbackinformation from the temperature sensors 80, for processing by thecontroller 52, e.g., to govern the application of energy and thedelivery of processing fluid. The I/O device 54 also includes agraphical user interface (GUI), to graphically present processinginformation to the physician for viewing or analysis.

II. Monitoring and Control of Reuse

The handle 28 and the catheter tube 30 form an integrated constructionintended for a single use and subsequent disposal as a unit.Alternatively, the handle 28 can comprise a nondisposable componentintended for multiple uses. In this arrangement, the catheter tube 30,and components carried at the end of the catheter tube 30 comprise adisposable assembly, which the physician releasably connects to thehandle 28 at time of use and disconnects and discards after use. Thecatheter tube 30 can, for example, include a male plug connector thatcouples to a female plug receptacle on the handle 28.

To protect patients from the potential adverse consequences occasionedby multiple use, which include disease transmission, or material stressand instability, or decreased or unpredictable performance, thecontroller 52 includes a module 48 that controls use of the device 26.

In the illustrated embodiment (see FIG. 6), the device 26 is supplied aspart of a kit 200 that includes, together with the device 26, a usagekey card 202. The kit 200 packages the device 26 and usage key card 202as a unitary, single use item in a sterile fashion within peripherallysealed sheets of plastic film material that are torn or peeled away atthe instance of use.

The presence of the device 26 and user key card 202 packaged together inthe kit 200 verifies to the physician or user that device 26 is sterileand has not be subjected to prior use. The physician or user is therebyassured that the device 26 meets established performance and sterilityspecifications. No unused device 26 is supplied in the kit 200 without ausage key card 202, and vice versa.

The usage key card 202 incorporates a storage medium 204 that isreadable by the module 48. The storage medium 204 contains informationthat enables at least two use control and monitoring functions.

The first use control and monitoring function of the usage key card 202occurs prior to use of the device 26 in association with the generator38. To enable use of the generator 38 in association with the device 26,the physician must first present the usage key card 202 for reading bythe module 48. To enable use of the device 26, the controller 52 mustthen find that the usage key card 202 meets the criteria necessary forits registration by the controller 52. The criteria are designed toindicate the absence of a prior use, either in absolute terms or interms of a period of use outside a predetermined time period. If thecriteria are not met, the controller 52 will not register the usage keycard 202, and the controller 52 will also not enable use of thegenerator 38 in association with the device 26. Further details of theregistration function of the controller 52 will be described later.

The second use control and monitoring function of the usage key card 202occurs if the criteria are met and registration of the usage key card202 occurs. During permitted use of the device 26 in association withthe generator 38, the storage medium 204 of the usage key card 202remains in the module 48 and receives, via the module 48, data generatedby the controller 52 recording operating parameters and performance ofthe device 26. The storage medium 204 of the usage key card 202 retainsand organizes the data for further off-line storage and processing.Further details of the data retention function will be described later.

The usage key card 202 can be variously configured. In the illustratedembodiment (see FIG. 7), the usage key card 202 comprises acomputer-readable storage medium 204 housed within a conventional 3.5inch floppy disk 206. In this arrangement, the module 48 comprises aconventional floppy disk drive 208 (see FIG. 8) capable of reading datafrom and downloading data to the storage medium 204 of the disk 206.

Alternatively, the usage key card 202 can take the form of a PC card,flash memory device, or magnetic card. In these alternative embodiments,the module 48 comprises a data reading and writing device compatiblewith the storage medium of the card 202.

As FIG. 7 shows, the storage medium 204 of the usage key card 202contains at least two pre-formatted files 210 and 212. The first file210 contains a unique identification code 214 capable of being read bythe module 48 and registered by the controller 52. The second file 212is formatted to receive and retain operational and performance datagenerated by the controller 52 to create from it a procedure log 220.

The identification code 214 contained in the first file 210 is createdto be unique to the particular usage key card 202. That is, each usagekey card 202 contains its own unique identification code 214. No twousage key cards share the same identification code 214. The uniqueidentification code 214 can comprise, e.g., a serial number uniquelyassigned to the particular device 26 found in the kit 200, or any otherunique code that is not repeated for any other usage key card 202. Thecode 214 itself can comprise letters, numbers, or combinations thereof.

As FIG. 8 shows, the module 48 reads the identification code 214 off theusage key card 202 for input to the controller 52. This identificationcode will be called the “instant identification code.”

Following pre-programmed rules, the controller 52 constructs andmaintains in non-volatile memory a use table 216. The use table 216contains all prior identification codes that meet the criteria to beregistered by the controller 52. These identification codes will becalled the “registered identification codes.”

Following pre-programmed rules, the controller 52 compares the instantidentification code 214 to all registered identification codes containedin the table 216. In the absence of a match between the instantidentification code and any registered identification code, thecontroller 52 updates the table, i.e., the controller 52 registers theinstant identification code by adding it to the table 216. Uponregistering the usage key card 202, the controller 52 also enables useof generator 38 in association with the device.

The presence of a match between the instant identification code and anyregistered identification code indicates the usage key card 202 has beenpreviously read by the module 48, which reflects a prior use of thedevice 26 or another device not packaged with the card 202. In thiscircumstance, the controller 52 does not add the duplicativeidentification code to the table 216 and does not enable use of thegenerator 38 in association with any device 26. Preferably, thecontroller 52 outputs to the GUI notice of prior use.

In an alternative arrangement, the controller 52 maintains for eachregistered identification code in the table 216 a time record 218. Thetime record 218 contains a value reflecting the period of time duringwhich energy was applied by the generator 38 during the previouspermitted use. In this embodiment, when a match occurs between theinstant identification code and a registered identification code, thecontroller 52 ascertains whether the time period of previous usecontained in the record 218 is less than a prescribed maximum timeperiod, e.g., 45 minutes. If so, the controller 52 enables a subsequentoperation of the generator 38 in association with the device 26, butonly for the time period remaining. The controller 52 updates the timerecord 218 as further use occurs. The controller 52 preferably outputsto the GUI the time period of permitted use remaining.

If the controller 52 ascertains that the time period of previous useequals or exceeds the prescribed maximum time period, the controller 52does not enable use of the generator 38. Preferably, the controller 52outputs to the GUI notice of prior use.

As FIG. 9 shows, the second file 212 contained on the storage medium 204of the usage key card 202 is formatted to receive, via the module 48,data that is generated by the controller 52 during permitted use of thedevice 26 in association with the generator 38. The file 212 retains thedata in a formatted array according to pre-programmed rules to create aprocedure log 220.

The content of the formatted log 220 can vary. For example, the log 220can document, by date of treatment and number of treatments, thecoagulation level (i.e., the depth at which the electrodes areinserted), the time duration of energy application, the magnitude ofenergy delivered by each electrode, and the coolant flow rate. Theprocedure log 220 can also record at pre-established intervals (e.g.,every 5 seconds) the temperatures of the electrodes and surroundingtissue, along other parameters, e.g., sensed impedance and powerdelivered by each electrode.

The procedure log 220 preferably records these values in a pre-formatteddata base format, to enable import of the values as data base items forstorage, processing, and retrieval by an off-line data processing device222 having a compatible data base processing application. The off-linedata processing device 222 reads processing log data from the usage keycard 202 (via a floppy disk drive 230 or otherwise compatible readingdevice).

The device 222 can process the data in various ways according to therules of the data processing application. The device 222 can, e.g.,create a print-formatted record of the procedure log 220 for printing ina hard copy version. The device 222 can also, e.g., process theprocedure logs for multiple devices and patients, to create historicalpatient treatment records, patient reimbursement records, and the likefor storage or retrieval. The device 222 thereby makes possible theestablishment and maintenance of an archival patient database byprocessing individual procedure logs.

As FIG. 6 shows, the kit 200 can also include a label 224 that ispre-applied or that can be applied by the physician to the usage keycard 202. The label 224 receives manually transcribed, visually readableinformation pertaining to the usage key card 202, e.g., the name of thepatient being treated by the device 26, the date of treatment, and thelike. In this way, usage key cards 202 can itself be physically storedand indexed.

As FIG. 6 also shows, the kit 200 can also include instructions 232 forusing the usage key card 202 in the fashion described. For example, theinstructions 232 can instruct the physician as to the need for havingthe usage key card 202 read by the module 48, in order to enable use ofthe device 26 in association with the generator 38. The instructions 232can also instruct the physician regarding the content of the procedurelog and the subsequent off-line processing options that are available.

As FIG. 7 shows, the storage medium 204 of the usage key card 202 canalso contain at least one additional formatted file 226 that providesdevice information 228, which characterizes the device 26 supplied inthe kit 200. For example, the device information 228, when read by themodule 48, can identify the type of device 26 in terms of itsoperational characteristics, the inclusion of temperature sensing, andreuse criteria (e.g., no reuse after a single use, or multiple usespermitted up a prescribed maximum number of uses, or multiple usespermitted up to a maximum time period of use, or multiple uses permittedup to a maximum application of RF energy). The file 226 can alsocondition the GUI to display the desired images and data formats, whichchange depending upon the treatment procedure using the device (e.g,treatment of GERD, fecal incontinence, or urinary incontinence). In onearrangement, the controller 52 can compare the device characteristicswith the operational characteristics of the controller 52 and generator38, and disable operation of the device 26 should the characteristics ofthe device 26 be incompatible with the characteristics of the controller52 and/or generator 38.

III. Graphical User Interface (GUI) for Monitoring and Controlling Reuse

In the illustrated embodiment (see FIG. 10), the radio frequencygenerator 38, the controller 52 with I/O device 54, and the fluiddelivery apparatus 44 (e.g., for the delivery of cooling liquid) areintegrated within a single housing 400. The I/O device 54 includes inputconnectors 402, 404, and 406. The connector 402 accepts an electricalconnector 408, to which the connector 42 of the selected treatmentdevice 26 is electrically coupled for use. The connector 404 accepts anelectrical connector 410 coupled to a patch electrode 412 (formono-polar operation). The connector 406 accepts an pneumatic connector414 coupled to a conventional foot pedal 416, when, when depressed,causes the delivery of radio frequency energy to the electrodes 66 onthe device 26. These connectors 402, 404, and 406 couple these externaldevices to the controller 52.

The I/O device 54 also couples the controller 52 to an array of membranekeypads 422 and other indicator lights on the housing 400, for enteringand indicating parameters governing the operation of the controller 52.

The I/O device 54 also couples the controller 52 to a displaymicroprocessor 474. In the illustrated embodiment, the microprocessor474 comprises, e.g., a dedicated Pentium®-based central processing unit.The controller 52 transmits data to the microprocessor 474, and themicroprocessor 474 acknowledges correct receipt of the data and formatsthe data for meaningful display to the physician. In the illustratedembodiment, the dedicated display microprocessor 474 exerts no controlover the controller 52.

In the illustrated embodiment, the controller 52 comprises an 68HC11processor having an imbedded operating system. Alternatively, thecontroller 52 can comprise another style of processor, and the operatingsystem can reside as process software on a hard drive coupled to theCPU, which is down loaded to the CPU during system initialization andstartup.

The display microprocessor 474 is coupled to a graphics display monitor420 in the housing 400. The controller 52 implements through the displaymicroprocessor 474 the graphical user interface, or GUI, which isdisplayed on the display monitor 420.

The GUI can be realized, e.g., as a “C” language program implemented bythe microprocessor 474 using the MS WINDOWS™ or NT application and thestandard WINDOWS 32 API controls, e.g., as provided by the WINDOWS™Development Kit, along with conventional graphics software disclosed inpublic literature.

The display microprocessor 474 is also itself coupled to the floppy diskdrive 208, previously described. The display microprocessor 474 can alsobe coupled to a keyboard, printer, and include one or more parallel portlinks and one or more conventional serial RS-232C port links orEthernet™ communication links.

Upon boot-up of the CPU (see FIG. 13), the operating system implementsthe START-UP function 510 for the GUI 424. The GUI 424 displays anappropriate start-up logo and title image (not shown), while thecontroller 52 performs a self-test.

Upon completion of the START-UP function (see FIG. 13), the controller52 conducts a CHECK function 512. The function 512 checks for thepresence of a usage key card 202 in the floppy disk drive 208. As beforedescribed, a valid usage key card 202 is a prerequisite for using agiven treatment device 26.

The absence of a usage key card 202 causes the controller 52 to commandthe display microprocessor 474 to generate a SETUP prompt 500 on thegraphics display monitor 420. FIG. 11 shows a representative SETUPprompt 500. When graphically implemented, as shown in FIG. 11, the SETUPprompt 500 leads the operator in a step-wise fashion through the tasksrequired to enable use of the generator 38. A first graphic fielddisplays one or more icons and/or alpha-numeric indicia 502 that promptthe operator to connect the electrical connector 42 of the treatmentdevice 26 to the connector cable 408. A second graphic field displaysone or more icons and/or alpha-numeric indicia 504 that prompt theoperator to insert a valid user key card 202 (i.e., floppy disk). Athird graphic field displays one or more icons and/or alpha-numericindicia 506 that prompt the user to select the standby-ready button 430on the housing 400 (see FIG. 10).

With the treatment device 26 connected and a user key card 202 insertedin the floppy disk drive 208, the actuation of the standby-ready button430 causes the controller 52 to enter the STAND-BY mode 508 (see FIG.13). In the STAND-BY mode 508, the controller 52 executes theREGISTRATION function 514, to determine whether the user key card 202inserted in the drive 208 contains a valid identification code 214.

The identification code 214 will not be deemed valid when the codealready exists in the use table 216 of the controller 52 with a timerecord 218 equal to or greater than the prescribed maximum, therebyindicating a completed prior use of the device 26. When theidentification code 214 is not valid, the REGISTRATION function 514commands the display microprocessor 474 to generate an EXCHANGE prompt516 on the graphics display monitor 420. FIG. 12 shows a representativeEXCHANGE prompt 516. When graphically implemented, as shown in FIG. 12,the EXCHANGE prompt 516 leads the operator in a step-wise fashionthrough the tasks of replacing the previously used device 26 and its keycard 202 with a new device 26 and its associated key card 202.

As shown in FIG. 12, a first graphic field displays one or more iconsand/or alpha-numeric indicia 518 that prompt the operator to disconnectthe electrical connector 42 of the previously used treatment device 26and to connect a new treatment device 26. A second graphic fielddisplays one or more icons and/or alpha-numeric indicia 520 that promptthe operator to remove the old user key card 202 and insert the new keycard 202 that accompanied the new treatment device 26 in the kit 200. Athird graphic field displays one or more icons and/or alpha-numericindicia 522 that prompt the user to again select the standby-readybutton 430 on the housing 400.

With the new treatment device 26 connected and the new user key card 202inserted in the floppy disk drive 208, selection of the standby-readybutton 430 causes the controller 52 to again enter the STAND-BY mode508, and again execute the REGISTRATION function 514 (see FIG. 13).

The presence of a valid identification code 214 on the user card 202causes the controller 52 to enter the READY mode 524. The operatordeploys the treatment device 26 to the intended treatment site. Theoperator locates the electrodes 66 in the desired orientation. Whendelivery of radio frequency energy is desired, the operator depressesthe foot pedal 416 (or selects the standby-ready button 430). In theillustrated embodiment, the controller 52 executes a prescribed PAUSEstate 528 (e.g., 8 seconds), and then commands the generator 38 to applyradio frequency energy through the electrodes 66 carried by thetreatment device 26.

The controller 52 includes an UPDATE function 526 (see FIG. 13). TheUPDATE function 526 registers the time period during which radiofrequency energy is applied using the device 26. The time is enteredinto the time record 218 of the use table 216 maintained by thecontroller 52. After a prescribed maximum period of use is registered(e.g., sixty minutes), the UPDATE function 526 interrupts application ofradio frequency energy to the electrodes 66, and prevents furtherdelivery by the generator 38 to the particular device 26.

In this circumstance, the UPDATE function 526 causes the controller 52to generate the EXCHANGE prompt 516. As previously described, theEXCHANGE prompt 516 requires the operator to replace the existing device26 and its key card 200 with a new device 26 and its associated key card200.

In the illustrated embodiment, while radio frequency energy is beingapplied during the READY mode 524, the controller 52 preferably monitorsimpedance and/or temperature conditions at the treatment site. Thecontroller 52 enters a DEFAULT mode 530 and returns to the PAUSE state528 when certain localized impedance and/or temperature conditions aresensed, e.g., when impedance is outside a prescribed range (for example,less than 50 ohms or greater than 1000 ohms); or electrode tiptemperature exceeds 100 degrees C.; or tissue surface temperatureexceeds 50 degrees C. In the PAUSE state 528, the controller 52 preventsthe application of radio frequency energy through the electrodes 66 fora prescribed period of time (e.g., 8 seconds), after which operation ofthe generator 38 using the foot pedal 416 or standby-ready button 430 isrestored.

Other details of the GUI during operation of the device 26 can be foundin co-pending U.S. patent application Ser. No. 09/305,123, filed May 4,1999 and entitled “Graphical User Interface for Association with anElectrode Structure Deployed in Contact with a Tissue Region,” which isincorporated herein by reference.

Various features of the invention are set forth in the following claims.

What is claimed is:
 1. A system for controlling use of a surgical devicefor treating a tissue region, the surgical device including a pluralityof electrodes for applying energy to the tissue region, the systemcomprising a storage medium associated with the device formatted tocontain a unique identification code that is readable by a controller,the controller determining if the storage medium meets a criterianecessary for registration by the controller, wherein if the criteria isnot met, the controller will not perform the registration, and agraphical user interface having a graphic display which generates on afirst screen an indicator to exchange the device for another device ifthe criteria is not met, the first screen appearing subsequent to thecontroller performing a self-test, and the first screen appearingsubsequent to a prior screen indicating the surgical device should beconnected.
 2. The system of claim 1, wherein in the absence of a matchbetween the unique identification code and a registered identificationcode, the controller registers the identification code and enables useof a generator to apply energy to the surgical device.
 3. The system ofclaim 1, wherein in the presence of a match between the uniqueidentification code and a registered identification code, the controllerdoes not add the identification code.
 4. The system of claim 2, whereinthe controller maintains for each registered identification code a timerecord reflecting a period of time energy was applied by the generatorto the surgical device.
 5. The system of claim 3, wherein if there isthe match between the unique identification code and the registeredidentification code, the controller determines if a time period ofprevious use of the surgical device contained is less than a prescribedperiod of time.
 6. The system of claim 5, wherein if the time period isless than the prescribed period of time then the controller enablessubsequent operation of the generator.
 7. The system of claim 5, whereinif the time period exceeds the prescribed period of time then thecontroller does not enable use of the generator.
 8. The system of claim1, wherein the storage medium is external of the surgical device.
 9. Thesystem of claim 1, wherein the controller includes a first data stateprior to downloading the identification code and a processing functionfor processing the identification code and entering into a ready modeenabling delivery of energy to the surgical device if the identificationcode correlates in a pre-established manner with the first data state.10. The system of claim 9, wherein the processing function operates inthe ready mode to change the first data state to a second data statethat prevents subsequent operation of the surgical device in response todownloading of the identification code.
 11. The system of claim 10,wherein in the ready mode the processing function includes an updatefunction that registers a time period during which energy is deliveredto the device and interrupts delivery after a prescribed maximum periodof time is registered.
 12. The system of claim 1, wherein when theidentification is not valid, a registration function commands thedisplay microprocessor to generate an exchange prompt on the graphicdisplay.
 13. The system of claim 12, wherein the exchange prompt leads auser in a step-wise fashion through tasks of replacing the surgicaldevice with a new surgical device.
 14. The system of claim 13, whereinthe first screen displays one or both of an icon and indicia to promptthe user to disconnect the surgical device.
 15. The system of claim 12,wherein the controller includes an update function to register a timeperiod in which energy is applied to the surgical device.
 16. The systemof claim 15, wherein after a prescribed maximum period of use isregistered, an update function interrupts application of energy to thesurgical device and prevents further delivery by a generator of energyto the surgical device.
 17. The system of claim 16, wherein the updatefunction causes the controller to generate an exchange prompt requiringthe user to replace the surgical device.
 18. A system for controllinguse of a surgical device comprising a controller to control operation ofthe device, a reader to download information to the controller, agraphics display monitor, and a storage medium containing anidentification code associated with the device that is read by thereader, the controller including a first data state prior to downloadingof the identification code and a processing function for processing theidentification code and either entering into a ready mode enablingdelivery of energy to the device if the identification code correlatesin a pre-established manner with the first data state or not enteringinto a ready mode if the identification code correlates to an alreadyregistered identification code, wherein if not entering into the readymode an indicator on the graphics display monitor is generated toexchange the device for another device, wherein such indicator appearson a screen which appears subsequent to the controller performing aself-test and subsequent to a screen which appears after the self-testto indicate a device should be connected.
 19. The system of claim 18,wherein the identification code will not be deemed valid if a codealready exists in the controller with a time record equal to or greaterthan a prescribed maximum.
 20. The system of claim 19, wherein if theidentification is not valid, a registration function commands ageneration of a prompt to change the device, and if the identificationis valid, the controller enters the ready mode.